banner
picture

China has implemented a new policy for initially imported non-special use cosmetics through Shanghai Pudong New Area. The cosmetics will only require filing with Shanghai FDA instead of registration with CFDA from Mar 1 2017 to Dec 21 2018. According to the detailed guidance released by CFDA on Jan 18 , the FDA will grant a filing certificate to the applicant after a priliminary review of application dossiers, then the applicant can start to import. This new policy offers international companies dealing in non-special use cosmetics a fast channel to enter into Chinese market. Now CFDA officially expand the practice of imported non-special use cosmetics filing management in Pudong to other 10 FTZs...

Latest News

More

Comparison between Pudong Filing and CFDA Licensing

 Pudong FilingCFDA Licensing
Supervision After submit the filling files by the responsible person and get the electronic certificate, the cosmetics are allowed to import. Import cosmetics are allowed to import after the application approved by the CFDA.
Safety requirement

Requirements are same

The filing aims at adjusting the supervision mode without lower the requirements for product safety.

Dossier requirements
Requirements are same
Product testing

Requirements are same

The filing also requires toxicology testing including animal testing.

Safety assessment
Requirements are same
Authorization

Requirements are same

Oversea cosmetic manufacturers authorize a domestic entity to be the responsible agent/person, and clarify the scope and period of authority by signing the <Power of Attorney>

Responsible agent/person

1. The domestic responsible person should be a business entity located in Shanghai Pudong New Area.

2. The person is responsible for importation, operation and safety of the product, including appointing a specialist for quality and safety management, building product safety management, traceability and adverse effect reporting systems and recalling products.

3. One oversea cosmetic manufacturer can appoint more than one responsible person in China. But one product can only have one domestic responsible person.

1. The responsible agent should be an independent legal personality registrated in China.

2. The responsible agent in China is only responsible for the registration.

3. One oversea cosmetic manufacturer can only appoint one responsible agent in China.

Required timeAfter one week of a priliminary review of application dossiers, cosmetics can be imported if approved.Three to four months

Filing Process

process

Experts Say

  • Eliza Li | REACH24H

    Non-special products especially baby products and season-specific products can choose to take full use of Pudong trial to enjoy its flexibility. But stakeholders should keep in mind that although filing management apparently shortens the review time, it doesn’t reduce control of product quality and safety, sometimes it can be even stricter...[more]

  • Kathy Lou | REACH24H

    The CFDA licensing and Pudong filing can’t be applied for simultaneously. For products already obtained Pudong filing certificate, if the applicant wants to import products from other ports rather than Pudong, he shall cancel the certificate first. If products have been disapproved by CFDA, Pudong filing is not applicable.

  • Vian Fang | REACH24H

    The standards for cosmetic safety evaluation are changing constantly. Cosmetic companies can keep track of the most recent compliance requirements and review comments on products in the process of filing on the Pudong filing system.

  • Nina He | REACH24H

    Pudong filing requires more qualifications for the responsible person who shall have a real office (not only the registered office) with quality management staff and capability of cosmetic importation.

  • Marylene Zhan | REACH24H

    The preliminary review conducted by Shanghai FDA is actually stricter than CFDA's review. Some comments are even not proposed by CFDA before.

  • Inna Fu | REACH24H

    It should be noted that the paper dossiers shall be exactly the same as the e-dossiers submitted online, even the position of stamps.

Consultation

Image CAPTCHA
Enter the characters shown in the image.

ChemLinked Cosmetic Portal was created to provide cosmetic regulatory information for China and the rest of the Asia Pacific region to meet the growing demand for clear and concise regulatory advice and market intelligence.

ChemLinked is based in China, our office hour is 9:00 - 17:30 GMT+8 Beijing time.

Email: contact@chemlinked.com
Skype:  ChemLinked Official
Phone: +86 (0)571 8700 7535 Follow us:

© 2012-2018 ChemLinked   Term of Use   Privacy

SUBSCRIBE TO THE PAGE $ 199

Access to existing paid resources:
  • locked news and expert article
  • 1 E-translations=$ 270
  • 1 webinar=$ 99
Access to future paid resources (updated within one year as of the subscription)
  • 1 upcoming webinar=$ 99
  • More news and expert articles
zhedie SUBSCRIBE TO THE PAGE
FREE TRIAL SUBSCRIBE